Senior Mechanical Engineer

Company: BD (Becton, Dickinson and Company)
Location: San Jose
Posted on: June 8, 2021

Job Description:

Job Description Summary

Job Description

As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or sustaining engineering activities through the application of quality engineering skills for medical devices. For new product development activities, this person will handle projects and tasks, from product inception through product launch and maintenance and will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements. For sustaining product activities, this person will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established BD standards of quality. Successful performance requires close work with quality management, operations, suppliers, and/or BD associates to assure compliance with all BD policies, procedures, and practices.

Job duties include: Provide critical quality engineering direction to projects with respect to quality engineering tools/principals. Apply technical principles, theories, concepts, techniques, and quality sciences/tools. Develop solutions to routine problems of moderate scope. Provide audit support such as preparation and closure. Monitor and analyze in process inspection, process control activity, waste on reject rates, PM compliance, environmental control, and customer complaint levels. Lead and assure appropriate CAPA activities to accomplish internal/external objectives. Assure that new and modified equipment, materials, test procedures, measurement systems and sample plans are appropriately validated, documented and controlled.

ESSENTIAL JOB FUNCTIONS

• All responsibilities and duties specified within the QE job description
• Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/pronciples, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.
• Applies moderate level application of technical principles, theories, concepts, techniques, and quality sciences/tools.
• Develops solutions to routine problems of moderate scope.
• Follows company procedures and makes basic procedural updates.
• Demonstrates working knowledge of applicable regulatory, Corporate, and/or Unit requirements.
• Is an extended team member representing Site Quality on new product development projects and a team member for sustaining engineering projects.
• Provides audit support (preparation, closure, etc. activities).
• Establishes a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, waste an reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and documenting continuous improvement projects.
• Leads and assures appropriate CAPA activities to accomplish internal/external objectives.

PREFERRED SKILLS

• A Master's degree in Engineering or related field of study AND One (1) year of experience in the job offered or a related occupation.
• Training in statistics.
• Knowledge of design controls
• Ability to provide support to internal/external audits
• Proficiency in Minitab of other atatistical software

REQUIREMENTS

• Class I/ II / III Medical device manufacturing or pharmaceutical industry experience
• Proficiency in written and verbal communication skills
• Bachelor's Degree (engineering or similar field preferred)
• Minimum 2 years relevant experience or a combination of higher education and relevant experience
• MS Excel, Word

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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Primary Work Location

USA NE - Holdrege

Additional Locations

Work Shift

Keywords: BD (Becton, Dickinson and Company), San Jose , Senior Mechanical Engineer, Other , San Jose, California